Accelerated Approval For PCSK9 Inhibitors Not Up For Discussion, FDA Tells Panel
FDA asked its advisory committee not to discuss accelerated approval for Sanofi/Regeneron's Praluent and Amgen's Repatha; panelists wanted to discuss the idea anyway, however, given uncertainty around the reliability of LDL-cholesterol as a surrogate.
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How Much Is A Priority Review Worth? $67.5 Million, Sanofi/Regeneron Say
Companies’ decision to purchase and redeem BioMarin’s priority review voucher for their PCSK9 inhibitor alirocumab sets the first public benchmark for a voucher’s value and shows the potential advantages to be gained for sponsors in a race to market.
Wary Of Surrogates, Payers Seek Outcomes Data For PCSK9 Class
Regeneron/Sanofi and Amgen stress the strengths of the Phase III PCSK9 development programs at the American College of Cardiology annual meeting. The mechanism of action holds appeal, but development is taking place at a time of skepticism about surrogate CV markers, following failed trials of other drugs.
Electronic Records: US FDA Updates Guidelines On Use In Clinical Investigations
Revised draft guidance includes recommendations on preparing for FDA inspections, considerations for real-world data and digital health technologies, and the need for service level agreements between sponsors and IT providers.